Advertisement

Performance Evaluation of a New Mobile POC Lipids Analyzer

  • Shi-Yann Cheng
  • Tung-Meng Tsai
  • Yen-Yu Chen
  • Po-Jung Lai
  • Tai-I Chen
  • Tsai-Jung Chen
  • Chieh-Hsiao ChenEmail author
Original Article
  • 11 Downloads

Abstract

Objectives

Hyperlipidemia, excessive amounts of fat and fatty substances in the blood, is a major risk factor for cardiovascular disease. The measuring of fat or fatty substance in blood is usually obtained through a blood lipid test which includes total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL) and high-density lipoprotein (HDL). In the Medical Device industry, Point-of-care (POC) methods provide fast, portable and easy to use devices suitable for rapid determination of Lipid levels. Here, we evaluated the analytical performance of PixoTest POCT Lipid System (iXensor Co., Ltd.), a newly developed POC lipid panel analyzer.

Materials and Methods

PixoTest POCT Analyzer accuracy evaluation with the Cobas c111 Analyzer (Roche Diagnostics Ltd.) as a reference method was carried out according to CLSI EP 09-A3 guidelines. This study enrolled one hundred and twenty (120) subjects and conducted over three (3) clinical sites (40 subjects each), administered through nine (9) trained operators (total) performed under manufacturer’s protocol using three (3) reagent lots per blood sample (capillary & venous). Linear regression, bias plot and other statistical analyses were extrapolated from the test data in this study.

Results

Passing-Bablok regression analysis of the data between PixoTest POCT System and Roche Cobas c111 Analyzer with the venous blood showed a slope of 1.03, an intercept of − 0.1 and correlation coefficient of 0.99. The results for capillary blood showed a slope of 1.01, an intercept of − 0.04 and correlation coefficient of 0.99. Passing-Bablok regression analysis of the data (n = 120) from the comparison between the PixoTest POCT System and Roche Cobas c111 Analyzer with the TC venous blood of total 3 lots at 3 sites showed a slope of 0.99, an intercept of − 0.337 and correlation coefficient of 0.995 and the TC capillary blood showed a slope of 0.99, an intercept of − 0.105 and correlation coefficient of 0.984. TG venous blood of total 3 lots at 3 sites showed a slope of 0.99, an intercept of 0.0246 and correlation coefficient of 0.998 and TG capillary blood showed a slope of 0.99, an intercept of − 0.329 and correlation coefficient of 0.998. HDL venous blood showed a slope of 0.99, an intercept of − 0.0297 and correlation coefficient of 0.987 and the HDL capillary blood showed a slope of 0.99, an intercept of − 0.0403 and correlation coefficient of 0.989.

Conclusions

The evaluation results of PixoTest POCT system’s accuracy, linearity, and correlation with Roche Cobas c111 Analyzer, the PixoTest POCT System displayed great performance results for all evaluated data points. Thus, the PixoTest POCT System is capable of providing accurate and reliable lipid measurements in the POC setting.

Keywords

Point-of-care (POC) testing Lipids Total cholesterol (TC) Triglycerides (TG) High-density lipoprotein (HDL) PixoTest 

References

  1. 1.
    World Health Organization. Health topics: Cardiovascular diseases. http://www.who.int/topics/cardiovascular_diseases/en/.
  2. 2.
    Scarborough, P., Wickramasinghe, K., Bhatnagar, P., et al. (2011). Trends in coronary heart disease 1961–2011. London: British Heart Foundation.Google Scholar
  3. 3.
    New, M. I., Roberts, T. N., Bierman, E. L., & Reader, G. G. (1963). The significance of blood lipid alterations in diabetes mellitus. Diabetes, 12, 208–212.CrossRefGoogle Scholar
  4. 4.
    Frantz, I. D., Dawson, E. A., Ashman, P. L., Gatewood, L. C., Bartsch, G. E., Kuba, K., et al. (1989). Test of effect of lipid lowering by diet on cardiovascular risk. The Minnesota Coronary Survey. Arteriosclerosis, Thrombosis, and Vascular Biology, 9, 129–135.Google Scholar
  5. 5.
    Ravelli, A., van der Meulen, J. H. P., Osmond, C., Barker, D., & Bleker, O. (2000). Infant feeding and adult glucose tolerance, lipid profile, blood pressure, and obesity. Archives of Disease in Childhood, 82, 248–252.CrossRefGoogle Scholar
  6. 6.
    Department of Health. (2009). Putting prevention first. NHS Health Check: Vascular risk assessment and management. Best practice guidance. London: Department of Health.Google Scholar
  7. 7.
    Pai, N. P., Vadnais, C., Denkinger, C., Engel, N., & Pai, M. (2012). Point-of-care testing for infectious diseases: Diversity, complexity, and barriers in low- and middle-income countries. PLOS Medicine, 9, e1001306.CrossRefGoogle Scholar
  8. 8.
    Rapi, S., Bazzini, C., Tozzetti, C., Sbolci, V., & Modesti, P. A. (2009). Point-of-care testing of cholesterol and triglycerides for epidemiologic studies: Evaluation of multicare-in system. Translational Research, 153(2), 71–76.CrossRefGoogle Scholar
  9. 9.
    Whitehead, S. J., Ford, C., & Gama, R. (2014). A combined laboratory and field evaluation of the Cholestech LDX and CardioChek PA point-of-care testing lipid and glucose analysers. Annals of Clinical Biochemistry, 51(Pt 1), 54–67.CrossRefGoogle Scholar
  10. 10.
    Panz, V. R., Raal, F. J., Paiker, J., Immelman, R., & Miles, H. (2005). Performance of the CardioChek PA and Cholestech LDX point-of-care analysers compared to clinical diagnostic laboratory methods for the measurement of lipids. Cardiovascular Journal South Africa, 16(2), 112–117.Google Scholar
  11. 11.
    Batki, A. D., Holder, R., Thomason, H. L., & Thorpe, G. H. G. Boehringer Mannheim Accutrend GC meter for the determination of blood glucose and cholesterol. Medical Devices Agency evaluation report 1995 MDA/95/11.Google Scholar
  12. 12.
    NHS Purchasing and Supply Agency. (2009). Buyer’s guide. Point-of-care testing for cholesterol measurement.Google Scholar
  13. 13.
    Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. (2001). Executive summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA, 285(19), 2486–2497.  https://doi.org/10.1001/jama.285.19.2486.CrossRefGoogle Scholar

Copyright information

© Taiwanese Society of Biomedical Engineering 2019

Authors and Affiliations

  1. 1.School of MedicineChina Medical University and Beigang HospitalTaichungTaiwan
  2. 2.iXensor Co., LtdTaipeiTaiwan
  3. 3.Department of Nursing and Department of UrologyChina Medical University Beigang HospitalYunlinTaiwan

Personalised recommendations